Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Abc unitray ssp kits have a false negative in lane 13. internal investigation confirmed by sequence based typing that the customer had a sample type with a a*32:04 allele. therefore lane 13 has a confirmed false negative in the affected kits. however the primer mix in lane 13 is functioning as designed. the a*32:04 allele has an undefined sequence region which had not been confirmed through testing. the worksheet is incorrect in listing this allele as positive for lane 13.